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This handbook will discuss a topic that has been discussed at various ICDRA for the last 16 years: Counterfeit
Medicines. As regulators, we know what we mean when we say counterfeit medicine. There may be small differences
in our different national legislations but certainly we make no confusion between counterfeit medicines,
substandard medicines and legitimate generic medicines. We know that counterfeit medicines are a global public
health menace causing death, disability and injury. They destroy the credibility of health systems and waste precious
human and financial resources. They are found in all countries, both developed and developing.

Responding to the growing public health crisis of counterfeit drugs, and the call by the WHO Member countries at the
ICDRA meeting in Madrid in February 2004, many stakeholders, including the World Health Organization, in February
2006 agreed to establish the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The taskforce
has been active in forging international collaboration to seek global solutions to this global challenge and in raising
awareness of the dangers of counterfeit medical products...